pharmacoepidemiology and pharmacovigilance

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Pharmacoepidemiology and Pharmacovigilance
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Publisher : Academic Press
Release Date :
ISBN 10 : 012816381X
Pages : 144 pages
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Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews

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Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance provides understanding of up-to-date statistical methods applied to drug safety assessment from observational data. Postmarketing drug safety raises challenging methodological issues. Covers phamacovigilance using spontaneous reporting databases Explores statistical methods applied to drug safety assessment Features observational studies and provides understanding of up-to-date statistical methods.

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Textbook of Pharmacoepidemiology

The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the

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Pharmacoepidemiology

The fourth edition of Pharmacoepidemiology is an outstanding and fully comprehensive textbook, which will be an essential resource for all interested in the field—in academia, in regulatory agencies, in industry and in the law. Brian Strom’s classic textbook continues both to reflect the increased maturation of pharmacoepedemiology and

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Pharmacovigilance

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation,

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An Introduction to Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers

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Drug Safety

Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology : Study Designs - Types designs and their use

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Post Authorization Safety Studies of Medicinal Products

Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources

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Understanding Pharmacoepidemiology

A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will

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Using Medicines Information

This CD-ROM contains the full text of "The Red Book" and "Making Sense of The Red Book". It includes NHS regulations, amendments to the statutory instruments, terms of service, pharmaceutical regulations, health service circulars, and the white paper "The New NHS: Modern, Dependable". There is also a special program called "

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Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and

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Drug Utilization Research

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked

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Cobert s Manual of Drug Safety and Pharmacovigilance

Rev. ed. of: Manual of drug safety and pharmacovigilance / Barton L. Cobert. c2007.

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Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance and Pharmacoepidemiology. MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (Post authorisation safety study). Role of epidemiology in RMP (Risk Management Plan), CER (Competitive Efectiveness research), Post Marketing risk profile and

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Pharmacovigilance

The book "Pharmacovigilance" describes the pathway to understand that pharmacovigilance plays a specialized and pivotal role in ensuring ongoing safety of medicinal products. Written in plain English, the book is concise, jargon-free, and facilitates an understanding of fundamentals of pharmacovigilance and explores regulatory aspects involved in pharmacovigilance.

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